Effect of Monthly High-Dose Vitamin D Supplementation on Cardiovascular Disease in the Vitamin D Assessment Study : A Randomized Clinical Trial.

Importance: Cohort studies have reported increased incidence of cardiovascular disease (CVD) among individuals with low vitamin D status. To date, randomized clinical trials of vitamin D supplementation have not found an effect, possibly because of using too low a dose of vitamin D. Objective: To examine whether monthly high-dose vitamin D supplementation prevents CVD in the general population. Design, Setting, and Participants: The Vitamin D Assessment Study is a randomized, double-blind, placebo-controlled trial that recruited participants mostly from family practices in Auckland, New Zealand, from April 5, 2011, through November 6, 2012, with follow-up until July 2015. Participants were community-resident adults aged 50 to 84 years. Of 47 905 adults invited from family practices and 163 from community groups, 5110 participants were randomized to receive vitamin D3 (n = 2558) or placebo (n = 2552). Two participants retracted consent, and all others (n = 5108) were included in the primary analysis. Interventions: Oral vitamin D3 in an initial dose of 200 000 IU, followed a month later by monthly doses of 100 000 IU, or placebo for a median of 3.3 years (range, 2.5-4.2 years). Main Outcomes and Measures: The primary outcome was the number of participants with incident CVD and death, including a prespecified subgroup analysis in participants with vitamin D deficiency (baseline deseasonalized 25-hydroxyvitamin D [25(OH)D] levels <20 ng/mL). Secondary outcomes were myocardial infarction, angina, heart failure, hypertension, arrhythmias, arteriosclerosis, stroke, and venous thrombosis. Results: Of the 5108 participants included in the analysis, the mean (SD) age was 65.9 (8.3) years, 2969 (58.1%) were male, and 4253 (83.3%) were of European or other ethnicity, with the remainder being Polynesian or South Asian. Mean (SD) baseline deseasonalized 25(OH)D concentration was 26.5 (9.0) ng/mL, with 1270 participants (24.9%) being vitamin D deficient. In a random sample of 438 participants, the mean follow-up 25(OH)D level was greater than 20 ng/mL higher in the vitamin D group than in the placebo group. The primary outcome of CVD occurred in 303 participants (11.8%) in the vitamin D group and 293 participants (11.5%) in the placebo group, yielding an adjusted hazard ratio of 1.02 (95% CI, 0.87-1.20). Similar results were seen for participants with baseline vitamin D deficiency and for secondary outcomes. Conclusions and Relevance: Monthly high-dose vitamin D supplementation does not prevent CVD. This result does not support the use of monthly vitamin D supplementation for this purpose. The effects of daily or weekly dosing require further study. Trial Registration: clinicaltrials.gov Identifier: ACTRN12611000402943.

The Vitamin D Assessment (ViDA) Study: design of a randomized controlled trial of vitamin D supplementation for the prevention of cardiovascular disease, acute respiratory infection, falls and non-vertebral fractures.

Observational studies have shown that low vitamin D status is associated with an increased risk of cardiovascular disease, acute respiratory infection, falls and non-vertebral fractures. We recruited 5110 Auckland adults, aged 50-84 years, into a randomized, double-blind, placebo-controlled trial to test whether vitamin D supplementation protects against these four major outcomes. The intervention is a monthly cholecalciferol dose of 100,000IU (2.5mg) for an estimated median 3.3 years (range 2.5-4.2) during 2011-2015. Participants were recruited primarily from family practices, plus community groups with a high proportion of Maori, Pacific, or South Asian individuals. The baseline evaluation included medical history, lifestyle, physical measurements (e.g. blood pressure, arterial waveform, lung function, muscle function), and a blood sample (stored at -80°C for later testing). Capsules are being mailed to home addresses with a questionnaire to collect data on non-hospitalized outcomes and to monitor adherence and potential adverse effects. Other data sources include New Zealand Ministry of Health data on mortality, hospitalization, cancer registrations and dispensed pharmaceuticals. A random sample of 438 participants returned for annual collection of blood samples to monitor adherence and safety (hypercalcemia), including repeat physical measurements at 12 months follow-up. The trial will allow testing of a priori hypotheses on several other endpoints including: weight, blood pressure, arterial waveform parameters, heart rate variability, lung function, muscle strength, gait and balance, mood, psoriasis, bone density, and chronic pain.

A pilot survey of the impact of menstrual cycles on adolescent health.

BACKGROUND: The experience of menstruation and reproductive health by adolescent girls has been poorly studied in New Zealand. AIMS: To develop and pilot a Web-based survey of 16-year-olds' experience of menstruation and reproductive health with the eventual objective of conducting a larger population-based survey. A secondary aim was to report on the experience of menstrual and reproductive health in a group of 16-year-old girls in an urban setting. METHODS: A Web-based survey was developed and tested in 2006 with assistance of a multidisciplinary advisory group. The final version of the questionnaire had 146 questions in 11 sections and the topics were menstrual history, general health including use of medications, access to medical care or health information, sexual health, family history and personal information including smoking, height, weight, ethnicity, paid employment of parents, drug and alcohol use and exercise patterns. RESULTS: Seventy-five 16-year-old students completed the survey. Twenty-five per cent considered that their periods were quite a bit or a lot of trouble and 10% avoided certain activities during their menstrual periods, nearly 50% of girls always experienced some pain with every period, and 30% had seen a health professional about their period pains. Thirty-three stated that menstruation was moderately to severely painful and that daily activity was affected. Fifty per cent of girls were sexually active and of these 80% described it as painful. CONCLUSIONS: The Web-based survey was a successful approach to collecting information and could be used in a larger study.

Ethnicity and birth outcome: New Zealand trends 1980-2001: Part 2. Pregnancy outcomes for Maori women.

BACKGROUND: While traditionally Maori perinatal mortality has been similar to that of other ethnic groups, rates of preterm birth, small for gestational age (SGA) and teenage pregnancy have remained high. AIMS: To review current trends in preterm birth, SGA and teenage pregnancy for Maori during 1980-2001 and to highlight the major factors that have influenced Maori reproductive outcomes during this period. METHODS: De-identified birth registration data from 1 189 120 singleton live births and 5775 stillbirths were analysed for 1980-2001. Outcomes of interest included preterm birth, SGA and late fetal death while explanatory variables included maternal ethnicity, age and NZ Deprivation Index decile. Trend analysis was undertaken for 1980-1994 and multivariate logistic regression was used to explore risk factors for 1996-2001. RESULTS: During 1980-1994, Maori women had the highest preterm birth rates of any ethnic group in New Zealand, but in relative terms, inequalities declined as a consequence of a non-significant 7% fall in rates being offset by a statistically significant 30% increase for the European/other ethnic group. Rates of SGA were also higher amongst Maori women but declined by 25% during the 1980-1994 period. In addition, Maori women experienced significant socioeconomic gradients in SGA, with risk for Maori women in the most deprived NZDep areas being double that of Maori living affluent areas. Paradoxically, while Maori women had high rates of teenage pregnancy, this did not confer additional risk for preterm birth or SGA during the 1996-2001 period. CONCLUSIONS: While high rates of teenage pregnancy amongst Maori women appear not to confer additional risk for preterm birth or SGA, the social consequences of early childbearing may well be significant. The persistence of elevated rates of preterm birth and large socioeconomic gradients in SGA amongst Maori suggest that broader social and policy interventions are necessary if Maori are to achieve optimal birth outcomes in the coming decades.